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Does an Integrative Neuro-psychotherapy Program Foster the Adjustment in Depressed Stroke Patients? A Randomized Controlled Study.

This study has suspended participant recruitment.
(Project end after 3 years; prolongation was rejected)
Sponsor:
Collaborators:
Swiss National Science Foundation
University Hospital Inselspital, Berne
Information provided by:
University of Bern
ClinicalTrials.gov Identifier:
NCT01039857
First received: December 24, 2009
Last updated: January 11, 2013
Last verified: January 2013
History of Changes
  Purpose

This is an intervention study with patients after a non-progressive brain injury who suffer from depression. It will determine whether an integration of neuropsychological and psychotherapeutic techniques and an additional caregivers support program offers benefits to those in the process of coping with the effects of a stroke. We expect the integrative neuro-psychotherapy to be more effective in the treatment of emotional distress reactions following a stroke than the structured solution focused treatment.


Condition Intervention Phase
Adjustment Disorders
Non-progressive Brain Injury
 Behavioral: Neuropsychological Therapy, cognitive behavioral therapy, solution focused therapy
Behavioral: Integrative Neuro-Psychotherapy
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Does an Integrative Neuro-psychotherapy Program Foster the Adjustment in Depressed Stroke Patients? A Randomized Controlled Study.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Bern:

Primary Outcome Measures:
  • emotional distress measured by the Beck Depression Inventory (BDI-II) [ Time Frame: after the first 10 sessions (Progress), end of therapy, 6 months after end of therapy (follow-up) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Acceptance measured by the Trier Skala zur Krankheitsverarbeitung (TSK) [ Time Frame: end of therapy, 6 months after end of therapy (follow-up) ] [ Designated as safety issue: No ]
  • Awareness measured by the Awareness Questionnaire [ Time Frame: end of therapy, 6 months after end of therapy (follow-up) ] [ Designated as safety issue: No ]
  • Quality of life measured by the WHO Quality of Life-BREF (WHOQOL-BREF) [ Time Frame: end of therapy, 6 months after end of therapy (follow-up) ] [ Designated as safety issue: No ]

Enrollment: 25
Study Start Date: January 2010
Estimated Study Completion Date: December 2013
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Structured solution focused therapy
Neuropsychological Therapy, cognitive behavioral therapy, solution focused therapy
 Behavioral: Neuropsychological Therapy, cognitive behavioral therapy, solution focused therapy
Experimental: Integrative clarification therapy
Neuropsychological therapy, cognitive-behavioral therapy, emotion-focused techniques, clarification and interpersonal therapy techniques
 Behavioral: Integrative Neuro-Psychotherapy
Neuropsychological therapy, cognitive-behavioral therapy, emotion-focused techniques, clarification and interpersonal therapy techniques

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 66 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Non-progressive acquired brain injury
  • Time passed since brain injury equal or more than 4 months
  • Sufficient language ability to communicate and understand
  • Sufficient language ability in German
  • Currently in an outpatient setting
  • Diagnosis of an adjustment disorder (DSM-IV: 309.x, acute or chronic)
  • Age between 18 and 66 years

Exclusion Criteria

  • Events other than non-progressive acquired brain injury (e.g. neurodegenerative illness)
  • Presence of other chronic diseases (e.g. multiple sclerosis, sarcoidosis, Parkinson disorder, chronic pain disorder, rheumatic disorder)
  • Moderate to severe cognitive impairment
  • Prior history of psychiatric disease such as alcohol and drug abuse, personality disorders, obsessive-compulsive disorder, psychotic disorder
  • Suicidal or violent behaviour
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01039857

Locations
Switzerland
Bern University Hospital Dep. for Cognitive and Restorative Neurology
Bern, Switzerland, 3012
Sponsors and Collaborators
University of Bern
Swiss National Science Foundation
University Hospital Inselspital, Berne
Investigators
Study Chair: Hansjoerg Znoj, Prof. Dr. phil. University of Bern, Dep. of Clinical Psychology and Psychotherapy
Study Director: Helene Hofer, Dr. phil. Bern University Hospital, Outpatient Clinic for Cognitive and Restorative Neurology
Study Director: Martin Grosse Holtforth, Prof. Dr. phil. University of Zurich, Dep. of Psychology, Research Unit Psychotherapy for Depression
Study Director: Rene M Mueri, Prof. Dr. med. Bern University Hospital, Outpatient Clinic for Cognitive and Restorative Neurology
  More Information

No publications provided

Responsible Party: Prof. Dr. Hansjoerg Znoj, University of Bern, Department of Clinical Psychology and Psychotherapy
ClinicalTrials.gov Identifier: NCT01039857     History of Changes
Other Study ID Numbers: 012/08, SNF-100014-124574, 2009-2012, 1784 -Bern University Hospital
Study First Received: December 24, 2009
Last Updated: January 11, 2013
Health Authority: Switzerland: Independent Local Research Ethic Commission (Ethikkommission)

Keywords provided by University of Bern:
Psychotherapy
Depression
Adjustment Disorders
Neuropsychology
 Rehabilitation
Coping Skills
Stroke
Caregivers

Additional relevant MeSH terms:
Adjustment Disorders
Stroke
Brain Injuries
Mental Disorders
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries

ClinicalTrials.gov processed this record on May 22, 2013